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NOXOPHARM LIMITED Investor Presentation 2018

Nov 7, 2018

65437_rns_2018-11-07_8b705d44-b7cf-448b-9e0b-070ddd675f45.pdf

Investor Presentation

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Date: 8 November 2018 Sydney, Australia

ASX: NOX

Noxopharm Limited ABN 50 608 966 123

Registered Office and

Operational Office: Suite 3, Level 4 828 Pacific Highway Gordon NSW 2072 Australia

ASX Limited 20 Bridge Street SYDNEY NSW 2000

NOX releases latest corporate presentation

Highlighting Veyonda[] as a radio-enhancerR&D and commercial strategies

Sydney, November 8, 2018. Noxopharm (ASX: NOX) is pleased to release its latest corporate presentation. The presentation is part of an engagement with New Yorkbased public relations advisors, Life Science Advisors, relating to the Company’s outreach to the U.S. investment and medical markets.

Board of Directors

Mr Peter Marks Chairman Non-Executive Director

Graham Kelly, Noxopharm CEO, said, “The Company expects to be releasing clinical data from a number of clinical trials over the coming months. This updated presentation is a step towards keeping the market informed of the Company’s growing activities.”

……………………………………………………………..

Dr Graham Kelly Chief Executive Officer Managing Director

Dr Ian Dixon Non-Executive Director

About Veyonda[]

Veyonda[] (previously known as NOX66) is an innovative dosage formulation of the experimental anti-cancer drug, idronoxil, developed specifically to preserve the anti-cancer activity of idronoxil in the body and to enhance its drug-like behaviour. Idronoxil is a kinase inhibitor that works by inhibiting a range of enzymes, pre-eminent among which is sphingosine kinase, a key regulator of cell pro-survival mechanisms, and which is overexpressed in many cancer cells. Idronoxil also is an immuno-oncology drug, increasing the activity of the body’s innate immune system (NK cells).

About Noxopharm

Noxopharm is a clinical-stage Australian drug development company with offices in Sydney, Hong Kong and New York. The Company has a primary focus on the development of drugs based on an isoflavonoid chemical structure. Veyonda[] is the first pipeline product, with 3 other drug candidates for non-oncology indications under development in a subsidiary company.

Investor & Corporate Enquiries: Prue Kelly

M: 0459 022 445 E: [email protected]

Company Secretary: David Franks

T: +61 2 9299 9690 E: [email protected]

www.noxopharm.com

Forward Looking Statements

This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward-looking statements are based on estimates, projections and assumptions

made by Noxopharm about circumstances and events that have not yet taken place. Although Noxopharm believes the forward-looking statements to be reasonable, they are not certain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond the Company’s control that could cause the actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statement. No representation, warranty or assurance (express or implied) is given or made by Noxopharm that the forward-looking statements contained in this announcement are accurate and undue reliance should not be placed upon such statements.

D I S C O V E R D E V E L O P D E L I V E R

ASX: NOX

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Disclaimer

This presentation has been prepared by Noxopharm Limited (NOX or the Company). It should not be considered as an offer or invitation to subscribe for or purchase any shares in NOX or as an inducement to purchase any shares in NOX. No agreement to subscribe for securities in the NOX will be entered into on the basis of this presentation or any information, opinions or conclusions expressed in the course of this presentation.

This presentation is not a prospectus, product disclosure document or other offering document under Australian law or under the law of any other jurisdiction. It has been prepared for information purposes only. This presentation contains general summary information and does not take into account the investment objectives, financial situation and particular needs of an individual investor. It is not a financial product advice and the Company is not licenced to, and does not provide, financial advice.

This presentation may contain forward-looking statements which are identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘targets’, ‘expects’, or ‘intends’ and other similar words that involve risks and uncertainties. These statements are based on an assessment of past and present economic and operating conditions, and on a number of assumptions regarding future events and actions that, as at the date of this presentation, are expected to take place. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors many of which are beyond the control of the Company, its Directors and management.

Although the Company believes that the expectations reflected in the forward looking statements included in this presentation are reasonable, none of the Company, its Directors or officers can give, or gives, any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this document will actually occur or that the assumptions on which those statements are based are exhaustive or will prove to be correct beyond the date of its making. Readers are cautioned not to place undue reliance on these forward-looking statements. Except to the extent required by law, the Company has no intention to update or revise forward-looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this presentation.

Readers should make their own independent assessment of the information and take their own independent professional advice in relation to the information and any proposed action to be taken on the basis of the information. To the maximum extent permitted by law, the Company and its professional advisors and their related bodies corporate, affiliates and each of their respective directors, officers, management, employees, advisers and agents and any other person involved in the preparation of this presentation disclaim all liability and responsibility (including without limitation and liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use of or reliance on anything contained in, or omitted from, this presentation. Neither the Company nor its advisors have any responsibility or obligation to update this presentation or inform the reader of any matter arising or coming to their notice after the date of this presentation document which may affect any matter referred to in the presentation.

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Noxopharm At-a-Glance

  • Australian biotechnology company

  • Aim to bring Veyonda® dual-ac'on radio-enhancing/immuno-oncology drug

  • Listed Aug 2016: ASX (NOX)

  • Market cap: AUD$53 million

  • PIPELINE OF 1 CLINICAL AND 3 PRECLINICAL DRUG PROGRAMS Cash: AUD$9.6 million (Sept 30) (+ anVcipated >$3m R&D rebate)

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Investment Highlights

  • § Leader in the development of isoflavonoid-based therapeutics, an emerging field of drug development

  • § Novel family of G-protein inhibitors blocking key signaling pathways

  • § Key proprietary know-how on maximizing drug-like activity

  • § Targeted applications across multiple therapeutic areas of high unmet need, including cancer, cardiovascular disease, neurodegenerative disease and autoimmune diseases

  • § Commencing with Veyonda®, a sphingosine kinase inhibitor that boosts tumor response to chemotherapy and radiotherapy, major unmet needs

  • § Targeting 2022 for revenue generation through commercialization of Veyonda® in first instance as radio-enhancer

  • § Seasoned management and Board with deep public-company biotechnology experience

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  • § Founder and CEO, Graham Kelly, previously founded NASDAQ-listed companies - Novogen Ltd and Marshall Edwards Inc (MEI Pharma Inc). 4

Pipeline

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PRECLINICAL PHASE 1 PHASE 2
ONCOLOGY
Veyonda® Chemo-enhancement
Veyonda® Radio-enhancement DARRT
Veyonda® Radio-enhancement LuPIN
NON-ONCOLOGY
NYX-330 LDL Lowering
NYX-104 Neuro-protection
NYX-205 Peripheral neuropathy
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Overall Drug Development Strategy

  • Ø NOX to take Veyonda® through the registra6on process to marke6ng approval

  • Ø Final registra6on study to start H2 2019 as an enhancer of radiotherapy in late-stage prostate cancer (DARRT program). Objec6ve = marke6ng approval by 2022

  • Ø In 2019 extend DARRT into lung cancer, sarcomas and brain cancer to expand market opportuni6es and establish Veyonda® as standard-of-care radio-enhancer

  • Ø Confirm use of Veyonda® as enhancer of Lu-PSMA (Endocyte Inc) therapy in prostate cancer ahead of an6cipated marke6ng approval of Lu-PSMA in 2022

  • Ø Conduct Phase 2 study of Veyonda® as an enhancer of chemotherapy for pa6ents where cytotoxic chemotherapy is considered inappropriate for safety reasons, further establishing the broader u6lity of this drug candidate

  • Ø Establish NOX as tradi6onal biopharma company by extending the pipeline beyond oncology into a wide range of non-oncology indica6ons

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Overall Commercial Strategy

Ø NOX to remain an independent biopharma company based on proprietary IP enabling the development of a new class of drugs across a range of degenerative diseases

Ø Establish marketing collaborations with larger companies for larger markets Ø NOX to retain some rest-of-world territories for itself

Ø Hong Kong office established ahead of clinical and commercial activities in China Ø New York office established to raise profile of Company in the US investment and medical/patient sectors

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Oncology Pipeline

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PRECLINICAL PHASE 1 PHASE 2
ONCOLOGY
Veyonda® Chemo-enhancement
Veyonda® Radio-enhancement DARRT
Veyonda® Radio-enhancement LuPIN
NON-ONCOLOGY
NYX-330 LDL Lowering
NYX-104 Neuro-protecHon
NYX-205 Peripheral neuropathies
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Standard Radiotherapy – good but needs help ….

  • § Pros:

  • § poten2ally cura2ve if used sufficiently early

  • § Short course, usually well tolerated, rela2vely inexpensive

  • § Cons:

  • § Radia2on sickness caps amount and number of courses

  • §

  • § metastases

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  • §

= typically pallia<ve use only in advanced cancers

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known as an Abscopal Response

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An ABSCOPAL RESPONSE is a response to radiation in tumors outside the field of radiation

An abscopal response refers to an anti-cancer effect on nonirradiated lesions involving the following response spectrum:

  • Ø stable disease - <30% shrinkage; no new tumors

  • Ø Partial abscopal response - >30% shrinkage

  • Ø Complete abscopal response - no tumors evident

  • Ø A mixture in the one patient of all of the above

The mechanism of the abscopal response remain unknown but is believed to involve both immunological and epigenetic (miRNA) components

Radiotherapy for ParHal abscopal Complete abscopal single tumor response response

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Abscopal Responses Now Can Be Deliberately Induced

Abscopal responses now recognized as a likely quantum leap forward in the treatment of cancer.

Up to 2005, very rare phenomenon

The introduc8on of immuno-oncology (i-o) drugs including PD-1 and PD-L1 inhibitors has increased the frequency of abscopal responses

Exci8ng data shows combining i-o drugs with radiotherapy results in abscopal response rates of between 20-25% in certain cancers

Noxopharm believes that Veyonda® will surpass the abscopal response benefits seen with i-o drugs because:

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Cancer cell damaged by radiation and dies …..

… releasing an8gens and epigene8c signals ….

… that ac8vate immune cells (NK cells/T cells) that then aSack distant cancer cells.

a) Veyonda® has mul8ple mechanisms of ac8on, and

b) Veyonda® is ac8ve across a broader spectrum of cancers.

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IDRONOXIL: a mul.-ac.ng immuno-oncology drug

Idronoxil (Veyonda®ac-ve ingredient) works in 3 ways:

  1. Idronoxil kills cancer cells on its own ( ac#vates apopto#c pathways )

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  • By increasing chromosomal damage from radiotherapy by holding cells at a stage of mitosis(G2M) where they are most vulnerable to radia-on

  • By blocking the cancer cell’s ability to repair radia-on-induced DNA damage by blocking DNA repair mechanisms

  • Idronoxil s-mulates the body’s innate immune system (NK cells)

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  • Ø is a Sphingosine kinase primary regulator of prosurvival and growth signaling pathways

  • Ø Sphingosine kinase highly expressed in most cancers

  • Ø Idronoxil specifically inhibits sphingosine kinase, resul>ng in downstream inhibi>on of:

  • Cyclin dependent kinases (CDKs) = mito@c arrest

  • PARP-1, PARP-2, and topoisomerases 1 and 2 = block DNA repair

  • AKT, PI3K and mTOR pathways = inhibit mul>ple pro-survival pathways = apoptosis

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  • Ø Idronoxil does NOT inhibit sphingosine kinase in healthy cells

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Veyonda ®

Idronoxil: Addi,onal Immuno-oncology Mechanism

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In addion to its radio-enhancing acvity, idronoxil also works through an addional immuno-oncology mechanism Idronoxil acvates the innate immune system (monocytes and natural killer cells) Natural killer (NK) cells are the body’s primary defence mechanism against cancer cells

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Veyonda ®

Veyonda® - A Proprietary Formula5on of Idronoxil - Veyonda® delivers a proprietary pro drug form of idronoxil that…

Protects idronoxil from being inac=vated by the body’s detox enzymes Increases the half-life of idronoxil from 45 minutes to >10 hours

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Veyonda ® is a convenient-to-use, self-administered dosage form that preserves idronoxil in a bio-available, ac5ve form at therapeu5c blood levels over 24 hours.

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Veyonda® - A First-in-Class Radio-Enhancer AND Immuno-Oncology Drug

Veyonda ®

: Veyonda®

Selec?vely enhancing radia/on only in cancer cells, sparing healthy normal /ssue of radia/on 2-3 /mes Increasing the cancer cell-killing effect Working effec?vely across a broad spectrum of cancers Well tolerated in combina/on with radiotherapy

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Objec8ve is to make Veyonda® a standard cotreatment with radiotherapy

Veyonda ®

Well tolerated:

Combinaon (Veyonda® + radiotherapy) tested to date in 38 paents with no doselimi*ng toxicity

Short course of treatment for increased safety and reduced cost: 5 days of radiotherapy; maximum 21 days of Veyonda®

Use with pallia8ve dosages of radiotherapy: Allows radiotherapy to be used for tumors in sensive ssues (e.g. spine, heart)

Poten8al use across the cancer spectrum: Idronoxil ac*ve in the laboratory against all forms of cancer tested

Readily crosses blood-brain barrier: Able to be tested for primary and secondary brain cancer

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Veyonda® - Currently Being Evaluated as a Radio-enhancer in Two Clinical Programs

Veyonda ®

DARRT - D irect and A bscopal R esponse to R adio T herapy

LuPIN -[177] Lu te4um- P SMA-617 I n Combina4on with Veyo n da

18-Month Development Plan

Non-small cell lung cancer Sarcomas

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DARRT – A treatment regimen intended for pa8ents with late-stage solid cancers who are eligible for pallia8ve radiotherapy

Veyonda ® 9 DARRT

Maximising death of Prepares cancer cell cancer cells by blocking DNA for maximum repair of DNA. Blocking post-radia8on radia8on damage. DNA repair. Primes NK cells. Radiotherapy Veyonda® Veyonda® Veyonda® ~~Days 1-5 Days 6-10 Days 11-18~~

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Veyonda ® DARRT

DIRECT RESPONSE

At a minimum, Veyonda ® is expected to lead to better DIRECT responses to radiotherapy by functioning as a radio-enhancer

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Shrinkage of Complete resoluIon
Irradiated tumor of Irradiated tumor
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ABSCOPAL RESPONSE

The best expected outcome would be an improved DIRECT response, plus and ABSCOPAL response driven by its i-o drug properIes

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----- Start of picture text -----

ParIal abscopal Complete abscopal
response response
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Veyonda® projected to provide meaningful

Veyonda ® 9 DARRT


surviv

al benefts
9
DARRT
+ Veyonda® + Veyonda®
PalliaFve
radiotherapy
Effect limited to
irradiated tumors
Efect on irradiated +
non-irradiated tumors
only
Symptoms (pain) + +++ +++
CLINICAL Quality of Life + ++ +++
BENEFIT Time to disease progression + ++ ++++
Overall survival + ++ ++++

NOTE: PalliaFve radiotherapy alone intended to relieve symptoms such as pain; it is not expected to deliver anything more than a temporary and minor effect on disease progression

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DARRT-1: Phase 1b clinical trial evalua<ng the safety and efficacy of Veyonda® in men with late-stage prostate cancer eligible for pallia<ve radia<on for pain and symptom management

Veyonda ® 9 DARRT

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Combining Veyonda® with palliative radiotherapy to determine:

  • Safety across three dose cohorts (400, 800, 1200 mg)

  • Determine dosage for Phase 2/3 registration study

  • Signals of efficacy to support expansion of trial to additional solid tumor indications (lung, sarcoma)

  • Secondary endpoints include:

  • Longer progression-free survival (through stable disease or abscopal response)

  • Change in tumor size in target irradiated or non-irradiated lesions measured by RECIST

  • PSA response

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DARRT-1 Prostate Cancer: Early clinical Evidence of Halt to Disease Progression

Veyonda ® 9 DARRT

Cohort 1 : 400 mg Veyonda®

  • 4 pa,ents

12 weeks:

  • 3 pa,ents with stable disease

  • 1 a,ent disease ro ression p p g

Cohort 2 : 800 mg Veyonda®

• 2 pa,ents

  • (+ 2 replacement pa,ents treated but yet to be reviewed)

12 weeks:

  • 1 pa,ent disease progression

  • 1 pa,ent par*al abscopal response

Cohort 3 : 1200 mg Veyonda®

  • 1 pa,ent

12 weeks:

  • 1 pa,ent par*al abscopal response

  • (+ 3 pa,ents treated but yet to be reviewed)

NOTE: All paents entered study with progressive disease. End-point of DARRT is to increase the me to disease progression which is measured by PSA levels and where even an abscopal response in the form of stable disease is a highly significant outcome for this paent populaon

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Veyonda ® DARRT

Case Study: Example of a Complete Abscopal Response

Pa3ent with metastaDc castrate-resistant prostate cancer . Being treated with pallia3ve radiotherapy for spinal lesions.

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Combined with Veyonda® produced a complete abscopal response within 2 months.

AHer 4 years remains lesion-free and with undetectable PSA levels

7/7/14 29/9/14 28/11/14 2/3/15 30/4/15
Total PSA 140 170 13 0.18 0.07

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DARRT-1 Prostate Cancer: Data Read-outs

Veyonda ® 9 DARRT

Cohorts 1, 2 and 3 Cohorts 1, 2 and 3 Cohort 4 6- & 12-week assessments 24-week assessments 12-week assessments End Q1 End of ~~Dec 2018~~ 2019 Q2 2019

Company planning to report 6-week and interim 12- and 24-weeks data from Cohorts 1-3 by year-end 2018

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DARRT: Broad PotenIal UIlity In Solid Tumors

Veyonda ® DARRT

PROGRAM STRATEGY 2018/2019 DARRT

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DARRT-1 DARRT-2 DARRT-3 DARRT-4 Prostate cancer Lung cancer Sarcomas Brain cancer (GBM) (current) Q1 2019 Q1 2019 Q3 2019

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Endocyte’s Lutetium-PSMA-617 Targeted Brachytherapy for Prostate Cancer

Veyonda ® 9 LuPIN

PSMA-617 is a pep2de that recognizes and targets prostate specific membrane an2gen (PSMA). 85-90% cases pf prostate cancer are PSMA +ve

Lu-PSMA-617 links radioac2ve lute2um isotope to PSMA617, delivering radioac2vity directly to prostate cells and sparing healthy 2ssue

  • Only 1/3 of pa2ents show durable responses

  • 2/3 of pa2ents fail to complete 36-week course of treatment due to not responding or relapsing during treatment

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  • Radia2on from 177-Lute2um only penetrates to a maximum of 2mm, limi2ng efficacy to micro-metastases and being much less effec2ve against larger lesions

Image Source: Endocyte

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NVS-ECYT Deal Shows Growing Interest in Targeted Radiotherapy and Lu-PSMA

Novar(s pending acquisi(on of EndoCyte for $2.1 billion Provides Novar(s access to 177 Lu-PSMA-617 (Lu-PSMA) currently being evaluated by Endocyte in a Phase 3 registra(onal study for metasta(c castra(on-resistant prostate cancer

Australian hospital currently running a Phase 1b trial (LuPIN-1) using Veyonda ® as a sensi(zing agent in combina(on with[177 ] Lu-PSMA-617 provided by EndoCyte

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implica-ons for Noxopharm if Veyonda® is shown to boost Lu-PSMA efficacy

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LuPIN: Phase 1b inves5gator-ini5ated dose finding study evalua5ng the safety and efficacy of Veyonda® in combina5on with Lu-PSMA-617 in men with advanced, metasta5c prostate cancer

Veyonda ® 9 LuPIN

Ra&onale: That combining Veyonda® with Lu-PSMA-617 will:

  • Poten5ally provide an abscopal response

  • Improve the response rates to Lu-PSMA-617

  • Ensure that the majority of men complete their full 36-week treatment course (compared to current 33% level)

  • Deliver a more durable response that will deliver meaningful increase in survival

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LuPIN-1 Study Design

Veyonda ® LuPIN

Enrollment : Late-stage prostate cancer -metasta3c castrate-resistant disease Trial Design : 6 x 6-weekly IV injec3ons of[177] Lute3um-PSMA-617 + 10 days Veyonda® with each injec3on

Two dosing cohorts : 8 pa3ents 400 mg Veyonda ® ; 24 pa3ents 800 mg Veyonda ®

: Two primary endpoints

  • Safety

  • Clinical response measured by PSA levels, scans and clinical evalua3ons at 3, 6 and 12 months

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Non-Oncology Pipeline

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----- Start of picture text -----

PRECLINICAL PHASE 1 PHASE 2
ONCOLOGY
Veyonda® Chemo-enhancement
Veyonda® Radio-enhancement DARRT
Veyonda® Radio-enhancement LuPIN
NON-ONCOLOGY
NYX-330 LDL Lowering
NYX-104 Neuro-protecHon
NYX-205 Peripheral neuropathies
----- End of picture text -----

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unmet medical needs

NYX-104

NYX-205

NYX-330

STATUS: Lead optimization

Lead op/miza/on

First-in-class neuro-protectant

To protect brain from secondary nerve damage caused by excitotoxicity associated with concussion, TBI, stroke and severe epilepsy

Blocks glutamate-induced calcium overload from intracellular and extra-cellular sources

Preclinical data demonstrates 56% reduc/on in excitotoxicity in mouse model of ischemic stroke

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First-in-class anti-inflammatory for peripheral neuropathy

Inhibits all major inflammatory cytokines and thromboxane; spares prostaglandins

  • Readily crosses animal blood nerve barrier and enters peripheral nerves

200 different causes of peripheral neuropathy

Clinical indications(s) currently being evaluated in animal models

First-in-class small molecule PCSK9 inhibitor

To inhibit binding between PCSK9 and LDL receptor

Poten/al once a day oral treatment to be used in combina/on with sta/ns to achieve beSer control of LDL cholesterol levels

Poten/al to allow lower sta/n dosage to avoid nega/ve side effects associated with sta/n use such as muscle damage and risk of diabetes

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Expected Upcoming Milestones

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Dec 2018 DARRT 12-week assessments (Cohorts 1,2,3)
1Q 2019 DARRT 24-week assessments (Cohorts 1,2,3)
1Q 2019 Initiation of DARRT-2 (lung cancer)
1Q 2019 DARRT 12-week assessment (Cohort 4)
1Q 2019 Completion of LuPIN-1 enrollment
1Q 2019 Commence planning of DARRT-3 (sarcomas)
2Q 2019 Interim Phase 1 LuPIN-1 results
3Q 2019 Initiation of DARRT-4 (brain cancer)
3Q 2019 Initiation of Phase 2/Phase 3 DARRT-5 (prostate cancer)

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Experienced Leadership Team

Executive Title Prior Experience
Graham Kelly, PhD Founder and CEO Novogen, Marshall
Edwards Inc (MEIP)
Greg van Wyk, MD Chief Medical Officer Eli Lilly
John Wilkinson PhD Chief Scientific Officer
(Oncology)
Biotron
James Bonnar Chief Scientific Officer
(Non-Oncology)
Neuren

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Key metrics

Number of Shares 121.9M: Free float 66.8%
Market Cap (1 Nov 2018) AU$73M
CEO
IPO price 20 cents Directors
12 month high/low $1.80/0.48 Other founders8
Others
Average daily turnover $0.54M
Cash position AU$ 9.6 (30 Sept 2018)

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Dr. Graham Kelly Chief Executive Officer [email protected]

D I S C O V E R D E V E L O P D E L I V E R

ASX: NOX

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